Cleared Abbreviated

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

K243428 · Dxtx Medical, Inc. · Radiology

Jul 2025

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K243428 is an FDA 510(k) clearance for the e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Dxtx Medical, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 17, 2025, 254 days after receiving the submission on November 5, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K243428 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2024
Decision Date	July 17, 2025
Days to Decision	254 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF